Regulatory Affairs Manager

3 giorni fa

Lazio, Italia Altro A tempo pieno

Per azienda cliente, realtà attiva nello sviluppo e nella produzione di farmaci, dispositivi medici, cosmetici e integratori, con un forte orientamento alla qualità e all'innovazione, siamo alla ricerca di un/una:La figura avrà un ruolo centrale nel garantire la conformità normativa dei prodotti lungo tutto il loro ciclo di vita, coordinando il team Regulatory e presidiando le attività di farmacovigilanza.Sarà il riferimento nei rapporti con le autorità competenti, organismi notificati e partner commerciali.Principali responsabilitàCoordinare tutte le attività regolatorie, coordinando le risorse del teamGarantire documentazione regolatoria sempre aggiornataAssicurare la conformità di farmaci, dispositivi medici, cosmetici e integratori alle normative nazionali ed europee (AIFA, EMA, Ministero della Salute)Gestire registrazioni e autorizzazioni all'immissione in commercio (inclusa procedura DCP).Collaborare con R&D, Qualità, Produzione e Marketing nella preparazione della documentazioneCurare etichettatura, fogli illustrativi e materiali informativi.Presidiare la farmacovigilanza: gestione segnalazioni, PSUR/PBRER, rapporti con AIFA/EMA, audit e sorveglianza post-marketing.Requisiti ideali7+ anni di esperienza in Regulatory Affairs e/o Pharmacovigilance in ambito farmaceutico oConoscenza avanzata di normativa nazionale ed europeaBuona conoscenza della lingua ingleseCapacità di gestione team e orientamento al risultato#J-*****-Ljbffr

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